Ultrasound-Guided Interscalene Block Versus Shoulder Pericapsular Nerve Group (PENG) Block for Hemidiaphragmatic Paralysis in Elective Shoulder Surgery: A Randomized Controlled Trial
概览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 70
- 主要终点
- Hemidiaphragmatic Paralysis (HDP)
概览
简要总结
This randomized controlled trial aims to compare the incidence of hemidiaphragmatic paralysis (HDP) following ultrasound-guided interscalene block (ISB) versus shoulder pericapsular nerve group (PENG) block in patients undergoing elective shoulder surgery under general anesthesia.
The primary objective is to determine whether the shoulder PENG block reduces the incidence of HDP compared with conventional intrafascial ISB. HDP will be assessed using ultrasound measurement of diaphragmatic excursion 30 minutes after block performance
详细描述
Interscalene block is widely used for shoulder surgery but is frequently associated with ipsilateral hemidiaphragmatic paralysis due to phrenic nerve involvement. The shoulder PENG block is a more distal pericapsular technique targeting articular branches and may reduce diaphragmatic impairment.
This prospective, parallel-group, randomized controlled trial will enroll 68 adult patients scheduled for elective shoulder surgery. Participants will be randomly assigned (1:1) to receive either ultrasound-guided intrafascial interscalene block or ultrasound-guided shoulder PENG block.
Both groups will receive 15 mL of 0.25% bupivacaine (total dose 37.5 mg). Diaphragmatic excursion will be measured at baseline and 30 minutes after block performance using M-mode ultrasonography by a blinded assessor.
The primary endpoint is hemidiaphragmatic paralysis defined as ≥25% reduction in diaphragmatic excursion from baseline. Partial and complete paralysis will be analyzed as a composite binary outcome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA physical status I-III
- •Scheduled for elective shoulder surgery under general anesthesia
- •Able to provide informed consent
排除标准
- •Pre-existing diaphragmatic dysfunction
- •Severe COPD or restrictive pulmonary disease
- •Neuromuscular disorders
- •BMI \> 40 kg/m²
- •Coagulopathy
- •Infection at injection site
- •Allergy to local anesthetics
- •Inability to undergo diaphragmatic ultrasound assessment
结局指标
主要结局
Hemidiaphragmatic Paralysis (HDP)
时间窗: 30 minutes after block performance
≥25% reduction in diaphragmatic excursion from baseline measured by ultrasound M-mode.
次要结局
- Complete hemidiaphragmatic paralysis (≥75% reduction or paradoxical motion)(30 minutes after block performance)
- Absolute and percentage change in diaphragmatic excursion(30 minutes after block performance)
- Total 24-hour tramadol consumption (mg)(postoperative 24 hours)
- NRS pain scores (from 0 to 10: 0 stands for no pain, 10 stands for severe pain)(postopertaive 2 hours, 6 hours, 12 hours, 24 hours)
- Rescue morphine consumption (mg)(postoperative 24 hours)